FSP Clinical Research Associate I

Job Description

Join Us as a Clinical Research Associate – Make an Impact at the Forefront of Innovation

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

Short role description

The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study.

The CRA is responsible for the preparation, initiation, monitoring and closure of assigned sites in clinical studies, in compliance with AZ Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies.

A CRA with longer tenure and experience may take on additional responsibilities that include additional tasks associated with LSAD.

CRAs might have different internal titles based on the experience level (CRA, Senior CRA). The experience level depends on the years of experience, performance record, level of independence in the role, ability to take on additional tasks or tutor more junior colleagues. The Director, Country Head may assign this internal title after confirmation with Senior Director, Cluster Head or Executive Director, Regional Head.

Typical Accountabilities

Contributes to the selection of potential investigators.

In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.

Trains, supports and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles.

Confirms that site staff have completed and documented the required trainings appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times.

Actively participates in Local Study Team (LST) meetings.

Contributes to National Investigators meetings, as applicable.

Initiates, monitors and closes study sites in compliance with AZ Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST.

Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate.

Updates CTMS and other systems with data from study sites as per required timelines.

Manages study supplies (e.g., etc), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable.

Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the Study specific Monitoring Plan. If required, determines and discusses with LSAD the correct timing and type of visits.

Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan.